Analyzing Biomarkers in Drug Development
Biomarkers as indicators of biological and pathogenic processes have been used for decades to diagnose patients and prescribe treatment. In the past 10 years, however, they’ve substantially changed drug development practices. The demand for analyzing biomarkers in drug development has increased dramatically with the advancement of precision medicine. In the drug development context, biomarkers that are indicative of mechanism of action, target engagement, and clinical outcomes have been employed to assess both the safety and efficacy of an intervention. More specifically, biomarkers have been used either to select patients for clinical trials, to make go/no-go decisions, to support registration and label claims, or to treat patients.
Bioanalytical Drug Tolerance Limit Prediction and Optimization Model Developed Through Machine Learning With TensorFlow
Award winning poster presented at the 14th WRIB
“The selection is based on novelty of the concept, utility of the approach and the presentation style. It was a difficult decision for us to select 1 winner from total of 11 posters since the posters are generally with high quality and have addressed common challenges in the field with solid data. The winning poster stands out for its novelty, applying machine learning to predict drug tolerance of ADA method. Drug tolerance is a critical parameter for ADA method performance and is often the most resource-intensive component of ADA assay development. Although more data may be needed to further evaluate the prediction accuracy prior to broad implementation, the machine learning approach has the potential to streamline ADA method development and significantly improve the efficiency of immunogenicity assessment.”
Bioanalysis of Liposome Drugs by LC-MS/MS
This webinar presents history, introduction, applications and regulatory considerations for liposomal drugs and also discusses the development and validation of LC-MS/MS methods for the quantitation of total (encapsulated plus free), encapsulated and free drug concentrations for liposome drug products.
Frontage Laboratories, Inc 2019
Frontage is a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals.
We offer our clients comprehensive services in analytical testing and formulation development, drug metabolism and pharmacokinetics (DMPK), bioanalysis, preclinical safety and toxicology and early phase clinical studies. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients.
We successfully assist clients to advance hundreds of molecules through development to commercial launch in global markets. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance.
AMAG Pharmaceuticals, Inc. Studies
Ciraparantag is in clinical development as a reversal agent for various anticoagulants including non-vitamin K oral anticoagulants (NOACs). Ciraparantag was previously shown to reverse the anticoagulant effects of edoxaban and enoxaparin, as measured by whole blood clotting time (WBCT).
Development And Validation Of LC-MS/MS Methods For The…
Guadecitabine (SGI-110), a dinucleotide of β‑decitabine and deoxyguanosine, is currently being evaluated in phase II/III clinical trials for the treatment of hematological malignancies and solid tumors. This article describes the development and validation of bioanalytical assays to quantify guadecitabine and its active metabolite β‑decitabine in human plasma, whole blood and urine using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Since β‑decitabine is rapidly metabolized further by cytidine deaminase, plasma and whole blood samples were kept on ice-water after collection and stabilized with tetrahydrouridine (THU) directly upon sample collection. Sample preparation consisted of protein precipitation for plasma and whole blood and dilution for urine samples and was further optimized for each matrix and analyte separately. Final extracts were injected onto a C6-phenyl column for guadecitabine analysis, or a Nova-Pak Silica column for β‑decitabine analysis. Gradient elution was applied for both analytes using the same eluents for each assay and detection was performed on triple quadrupole mass spectrometers operating in the positive ion mode (Sciex QTRAP 5500 and QTRAP 6500). The assay for guadecitabine was linear over a range of 1.0–200 ng/mL (plasma, whole blood) and 10–2000 ng/mL (urine). For β‑decitabine the assay was linear over a range of 0.5–100 ng/mL (plasma, whole blood) and 5–1000 ng/mL (urine). The presented methods were successfully validated according to the latest FDA and EMA guidelines for bioanalytical method validation and applied in a guadecitabine clinical mass balance trial in patients with advanced cancer.
CMC Product Development
Frontage’s CMC portfolio of services spans drug product development, analysis, delivery and supply, from proof-of-concept, preclinical stages through Phase III clinical trials and commercialization support. With proven success in developing drug products for novel, generic and consumer products, we focus our efforts on clients’ specific needs. Our formulation development experience and capabilities cover a wide range of dosage forms at IND, NDA, ANDA and 505(b)(2) project stages and applications.